Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery

University of Split

Status: Completed

Conditions: Irritant Contact Dermatitis

Treatments: Other: Emollient, moisturizing cream; Procedure: Sodium lauryl sulphate induced irritation

Study type: Interventional

Funder types: Other

Identifiers

NCT03231813

003-08/17-03/0001

Details and patient eligibility

About

Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model for testing efficacy of various topical preparations. Aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. Published clinical trials usually irritate volar aspect of forearms or upper back. Also, lower back and dorsal aspect of forearm are sometimes used.

Skin parameters vary depending on anatomic location of measured skin. There is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back.

Furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. Such differences are also possible in SLS irritation model. One study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9).

Moreover, there are regional variations of topical preparations absorption. Hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those variations could be explained by different corneocyte size and number of their layers between back and hands.

Skin baseline properties and response to irritation seem to be dependent on anatomic position. Those differences could mean different response to treatment. Since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. It could limit validity and usefulness of conducted trials. The aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.

Enrollment: 25 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• young, healthy volunteers who gave written informed consent

Exclusion criteria

• skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior the inclusion and during the trial, use of emollients three days prior the inclusion in the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 4 patient groups, including a placebo group

SLS irritation model and Treatment

Experimental group

Description:

SLS induced irritation on two sites each on forearms and back Emollient cream treatment

Treatment:

Procedure: Sodium lauryl sulphate induced irritation

Other: Emollient, moisturizing cream

SLS irritation model and No Treatment

Placebo Comparator group

Description:

SLS induced irritation on two sites each on forearms and back No treatment

Treatment:

Procedure: Sodium lauryl sulphate induced irritation

Sham irritation and Treatment

Sham Comparator group

Description:

Sham irritation (water) on two sites each on forearms and back Emollient cream treatment

Treatment:

Other: Emollient, moisturizing cream

Sham irritation and No Treatment

No Intervention group

Description:

Sham irritation (water) on two sites each on forearms and back No treatment